Intraoperative Tranexamic Acid Infusion Reduces Perioperative Blood Loss in Pediatric Limb-Salvage Surgeries: A Double-Blinded Randomized Placebo-Controlled Trial.

Abstract

Background: Limb-salvage surgery for malignant bone tumors can be associated with considerable perioperative blood loss. The aim of this randomized controlled trial was to assess the safety and efficacy of the intraoperative infusion of tranexamic acid (TXA) in children and adolescents undergoing limb-salvage surgery.

Methods: All participants were <18 years of age at the time of surgery and diagnosed with a malignant bone tumor of the femur that was treated with resection and reconstruction with a megaprosthesis. Exclusion criteria included anatomic locations other than the femur, reconstruction with a vascularized fibular graft, and a previous history of deep venous thrombosis, coagulopathy, or renal dysfunction. Participants were randomly allocated to either the TXA group (a preoperative loading dose infusion of 10 mg/kg of TXA followed by a continuous infusion of 5 mg/kg/hr until the end of surgery) or the placebo group (the same dosage but with TXA substituted with an infusion of normal saline solution). Intraoperative and perioperative blood loss were calculated with use of the hemoglobin balance method. Perioperative blood loss at postoperative day 1 and at discharge from the hospital were calculated. The total volumes of blood transfused intraoperatively and postoperatively were recorded. A statistical comparison between the groups was performed for blood loss and blood transfusion as well as for possible independent variables other than TXA, including age, body mass index, histopathologic diagnosis, tumor volume, preoperative hemoglobin level, type of resection, and the duration of surgery.

Results: A total of 48 participants, with a mean age of 12.5 ± 3.44 years (range, 5 to 18 years) and a male-to-female ratio of 1.18, were included. All participants were Egyptians by race and ethnicity. There were no minor or major drug-related adverse events. There was no significant difference between the groups with respect to intraoperative blood loss (p = 0.0616) or transfusion requirements (p = 0.812), but there was a significant difference in perioperative blood loss at postoperative day 1 (p = 0.0144) and at discharge from the hospital (p = 0.0106) and in perioperative blood transfusion (p = 0.023).

Conclusions: TXA can be safely infused intraoperatively in children and adolescents undergoing limb-salvage surgery, and it contributes significantly to the reduction of perioperative blood loss and transfusion requirements.

Level of evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.